144 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·November 11, 2010
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CEC·November 8, 2013
Dimension Free Thyroxine (FT4L) Flex reagent cartridge
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Recall
Terminated
·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018
Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CEC·March 5, 2018
Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Access Immunoassay Systems Free T4, Part Number: 33880
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·March 24, 2010
The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEC·April 12, 2010
Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·April 30, 2019
Access System-Free T4 Assay, B01902E, Catalog No. 33880
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·May 9, 2017
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CEC--·December 15, 2003
C10-4ec Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code IYN·July 3, 2025
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
FDA Recall
Terminated
·Natus Medical Inc·Product code ETY·June 27, 2005
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Recall
Terminated
·Ceg Enterprises Llc·Product code MCF·April 5, 2016
X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012
FDA Recall
Terminated
·X-Cel X-Ray Corp·Product code KPR--·November 12, 2002
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Recall
Open, Classified
·ZOLL Medical Corporation·Product code MKJ·February 13, 2025